NCT04876027已完成4 期
Dulaglutide and Calorie Restrict Diet (CRD) in Overweight/Obese Patients With Polycystic Ovary Syndrome
Shanghai 10th People's Hospital1 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2021年5月15日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- the change in visceral adipose tissue
研究概览
简要总结
Polycystic ovary syndrome (PCOS) is a common endocrine disorder, with a prevalence of 5% to 15% in premenopausal women. Patients with PCOS presents as abnormal menstruation, ovulation disorders and/or hyperandrogenemia, and often accompanied by insulin resistance and other metabolic abnormalities. Visceral fat dysfunction is an important factor in the onset of PCOS. GLP-1 receptor agonist is a glucagon-like peptide 1 analog, which is related to improving blood sugar control, weight loss and appetite suppression, and reducing cardiovascular risk. The purpose of this study was to compare whether the combined treatment of GLP-1 receptor agonists and calorie restrict diet reduced more visceral fat of overweight/obese patients with PCOS at the same weight loss (7%) compared with calorie restrict diet alone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female aged 18- 45;
- •Meet 2003 Rotterdam criteria;
- •overweight/obesity,BMI≥24kg/m2.
排除标准
- •any contraindication to dulaglutide (known or suspected hypersensitivity to dulaglutide or related products, previous acute pancreatitis or chronic pancreatitis, inflammatory bowel disease; personal history or family history of medullary thyroid carcinoma, or personal history of multiple endocrine neoplasia type 2)；
- •treatment with any other drugs that may interfere with the trial, including traditional Chinese medicine, contraceptives, metformin, GLP-1RA or pioglitazone within the last 3 months；
- •chronic kidney disease or severe liver dysfunction；
- •malignant tumors；
- •mental illness;
- •pregnancy or lactation；
- •inflammatory bowel disease;
- •recent participation in other weight-loss research projects within the last 3 months.
研究组 & 干预措施
GLP-1 RAs and calorie restrict diet group
Experimental
Intervention with GLP-1 RAs and calorie restrict diet until reaching the target weight loss(7%)
干预措施: GLP-1 RAs (Drug)
GLP-1 RAs and calorie restrict diet group
Experimental
Intervention with GLP-1 RAs and calorie restrict diet until reaching the target weight loss(7%)
干预措施: calorie restricted diet (Other)
calorie restrict diet group
Active Comparator
Intervention with calorie restrict diet until reaching the target weight loss(7%)
干预措施: calorie restricted diet (Other)
结局指标
主要结局
the change in visceral adipose tissue
时间窗: until achievement of the weight loss target,an average of 12 weeks
the change in visceral adipose tissue (pretreatment-post-treatment) after achievement of the weight loss target
次要结局
- systolic blood pressure(from randomization to the time of achievement of the weight loss target, an average of 12 weeks)
- fasting plasma glucose(from randomization to the time of achievement of the weight loss target, an average of 12 weeks)
- diastolic blood pressure(from randomization to the time of achievement of the weight loss target, an average of 12 weeks)
- fasting insulin(from randomization to the time of achievement of the weight loss target, an average of 12 weeks)
- pituitary prolactin(from randomization to the time of achievement of the weight loss target, an average of 12 weeks)
- Androstenedione(from randomization to the time of achievement of the weight loss target, an average of 12 weeks)
- menstrual frequency(from randomization to the time of achievement of the weight loss target, an average of 12 weeks)
- postprandial plasma glucose(from randomization to the time of achievement of the weight loss target, an average of 12 weeks)
- postprandial insulin(from randomization to the time of achievement of the weight loss target, an average of 12 weeks)
- aspartate aminotransferase(from randomization to the time of achievement of the weight loss target, an average of 12 weeks)
- Creatinine(from randomization to the time of achievement of the weight loss target, an average of 12 weeks)
- dehydroepiandrosterone sulfate(from randomization to the time of achievement of the weight loss target, an average of 12 weeks)
- controlled attenuation parameter(from randomization to the time of achievement of the weight loss target, an average of 12 weeks)
- total fat mass(from randomization to the time of achievement of the weight loss target, an average of 12 weeks)
- Total cholesterol(from randomization to the time of achievement of the weight loss target, an average of 12 weeks)
- Triglycerides(from randomization to the time of achievement of the weight loss target, an average of 12 weeks)
- low-density lipoprotein cholesterol(from randomization to the time of achievement of the weight loss target, an average of 12 weeks)
- luteinizing hormone(from randomization to the time of achievement of the weight loss target, an average of 12 weeks)
- follicle-stimulating hormone(from randomization to the time of achievement of the weight loss target, an average of 12 weeks)
- glycosylated hemoglobin A1c(from randomization to the time of achievement of the weight loss target, an average of 12 weeks)
- alanine aminotransferase(from randomization to the time of achievement of the weight loss target, an average of 12 weeks)
- homeostasis model assessment of insulin resistance(from randomization to the time of achievement of the weight loss target, an average of 12 weeks)
- high-density lipoprotein cholesterol(from randomization to the time of achievement of the weight loss target, an average of 12 weeks)
- serum uric acid(from randomization to the time of achievement of the weight loss target, an average of 12 weeks)
- free testosterone(from randomization to the time of achievement of the weight loss target, an average of 12 weeks)
- total testosterone(from randomization to the time of achievement of the weight loss target, an average of 12 weeks)
- Sex hormone binding globulin(from randomization to the time of achievement of the weight loss target, an average of 12 weeks)
- liver stiffness measurement(from randomization to the time of achievement of the weight loss target, an average of 12 weeks)
- total body fat(from randomization to the time of achievement of the weight loss target, an average of 12 weeks)
- total body lean(from randomization to the time of achievement of the weight loss target, an average of 12 weeks)
- total lean mass(from randomization to the time of achievement of the weight loss target, an average of 12 weeks)
- the change in subcutaneous adipose tissue(from randomization to the time of achievement of the weight loss target, an average of 12 weeks)
研究者
Zhang Manna
Director, Principal Investigator, Clinical Professor
Shanghai 10th People's Hospital
研究点 (1)
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